Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 100mg elemental iron/mL (1-mL, 5-mL, 10-mL single-dose vials)
Iron Deficiency Anemia
Indicated for iron deficiency anemia in adults who have intolerance to oral iron or have had unsatisfactory response to oral iron
Also indicated for iron deficiency anemia in adults who have nonhemodialysis-dependent chronic kidney disease
<50 kg: 20 mg/kg actual body weight IV infusion
≥50 kg: 1000 mg IV infusion
Repeat dose if iron deficiency anemia reoccurs
Dose expressed in mg of elemental iron; each mL contains 100 mg of elemental iron
Safety and efficacy not established
Adverse Effects
1-10%
Hypophosphatemia (serum phosphate <2 mg/dL) (3.5%)
Nausea (1.2%)
Rash (1%)
Postmarketing Reports
Cardiac disorders: Tachycardia
Gastrointestinal disorders: Abdominal pain, nausea and vomiting, constipation, diarrhea
General disorders and administration site conditions: Fatigue, pyrexia, chest pain, chills, Fishbane reaction, extravasation, influenzalike symptoms, injection site reactions
Immune system disorders: Anaphylactic/anaphylactoid reaction, hypersensitivity
Investigations: Hepatic enzymes increased
Musculoskeletal and connective tissue disorders: Back pain, muscle spasms, arthralgia, myalgia
Nervous system disorders: Dizziness, headache, paresthesia, dysgeusia, seizure, loss of consciousness, syncope
Psychiatric disorders: Anxiety
Respiratory, thoracic, and mediastinal disorders: Dyspnea, cough
Skin and subcutaneous tissue disorders: Erythema, urticaria, skin discoloration, rash, pruritus, sweating
Vascular disorders: Hypertension, hypotension, flushing, phlebitis
Extravasation at the injection site that may lead to irritation of the skin and potentially long-lasting brown discoloration at the site of injection has also been reported
Warnings
Contraindications
Hypersensitivity to ferric derisomaltose or any of its components
Cautions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, reported
Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis; monitor hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during therapy; do not administer to patients with iron overload
Pregnancy & Lactation
Pregnancy
There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Published studies on the use of IV iron products in pregnant women have not reported an association with adverse developmental outcomes; these studies cannot exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects
Animal data
- Iron complexes have been reported to be teratogenic and embryocidal in noniron-depleted pregnant animals
- Findings in animals may be due to iron overload and may not be applicable to patients with iron deficiency
- Animal reproduction studies of ferric derisomaltose administered to rats and rabbits during organogenesis caused adverse developmental outcomes including structural abnormalities and embryofetal mortality at doses ~0.09 and 0.4 times the maximum recommended human dose (MRHD) of 1000 mg, respectively, based on body surface area
- Administered intravenously to pregnant rabbits during organogenesis, from GD7 to GD20, at doses of 11, 25 and 43 mg Fe/kg/day; the dose of 43 mg Fe/kg/day (approximately 0.8 times the MRHD of 1000 mg, based on BSA) resulted in increased maternal mortality, abortion, and premature delivery, and increased postimplantation loss
- Adverse developmental findings at this dose included fetal mortality, reduced fetal weights, and fetal developmental variations and malformations (including domed head, cleft palate, microglossia, hydrocephaly, small brain); fetal malformations and reduced fetal weights were also noted in the 25 mg Fe/kg/day group (approximately 0.5 times the MRHD based on BSA)
Clinical considerations
- Untreated iron deficiency anemia in pregnancy is associated with adverse maternal outcomes (eg, postpartum anemia)
- Adverse pregnancy outcomes associated with iron deficiency anemia include increased risk for preterm delivery and low birth weight
- Risks to fetus associated with maternal severe hypersensitivity reactions
- Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products which may cause fetal bradycardia, especially during second and third trimester
Lactation
Available data on use in lactating women demonstrate that iron is present in breast milk
Data do not inform the potential exposure of iron for the breastfed child or the effects on milk production
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for ferric derisomaltose in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition
Clinical considerations
- Monitor breastfed children for gastrointestinal toxicity (constipation, diarrhea)
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron
Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin
Absorption
Peak plasma concentration: 408 mcg/mL (single 1000-mg dose)
AUC: 17,730 mcg⋅hr/mL (single 1000-mg dose)
Serum ferritin peaks ~7 days after an IV dose and slowly returns to stable levels after about 4 weeks
Distribution
Circulating iron is removed from plasma by cells of the reticuloendothelial system
Iron is bound to the available protein moieties to form hemosiderin or ferritin, the physiological storage forms of iron, or to a lesser extent, to the transport molecule transferrin
Elimination
Half-life: 27 hr (measured by serum total iron)
Owing to the size of the complex, ferric derisomaltose is not excreted by the kidneys
Small quantities of iron are excreted in urine and feces
Administration
IV Incompatibilities
Compatibility with other drugs has not been established
Do not mix with or physically add to solutions containing other drugs
IV Preparation
Visually inspect vial for particulate matter and discoloration before administration; product contains no preservatives
Each vial is single-dose only; discard unused portion
Withdraw appropriate volume of ferric derisomaltose and dilute in 100-500 mL of 0.9% NaCl
Final diluted concentration should be >1 mg iron/mL
IV Administration
Only administer when personnel and therapies are immediately available for treatment of serious hypersensitivity reactions
Infuse IV over at least 20 min
Extravasation of ferric derisomaltose
- May cause brown discoloration at the extravasation site, which may be long lasting
- Monitor for extravasation
- If extravasation occurs, discontinue administration at that site
Storage
Unused vials: Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Diluted solutions: Store at room temperature for up to 8 hr
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